Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act

On 19 November 2020 the FDA published the draft guidance for industry. Submit comments by 19 January 2021.

This draft guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act.

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